Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome



Status:Not yet recruiting
Conditions:Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:13 - 85
Updated:4/13/2015
Start Date:November 2011
Contact:William M Reisman, MD
Email:wmreisman@gmail.com
Phone:404-272-1637

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The purpose of this study is to define the reliability and accuracy of Near Infrared
Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and
noninjured extremities over time. We hypothesize that this technology, combined with vital
signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing
acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the
adequacy of fasciotomy in patients treated for ACS.

Acute compartment syndrome (ACS) is associated with lower leg trauma in up to 20% of high
energy injuries. ACS occurs when the pressure due to swelling exceeds the perfusion
pressure thereby cutting off blood flow to the leg. If untreated, the results can be
catastrophic with an insensate, contracted leg. Moreover, there is a high risk of
subsequent infection and even amputation. The treatment for ACS, a four compartment
fasciotomy, is aimed at releasing the pressure through two incisions from roughly the knee
to the ankle. Often due to wound expansion, the incisions require multiple debridements and
skin grafting to close. With fasciotomies, fractures are converted from closed to open
injuries. When left open for many days, the risk of infection and complications such as
nonunion increase significantly.

The only accepted objective method for diagnosis of ACS is to measure the pressure inside
the leg compartments by using a large gauge needle hooked to a pressure monitor. However,
these readings can be erroneous if not performed correctly. As such, ACS continues to be a
clinical diagnosis which is made based on the surgeon's experience and their interpretation
of the character of the injury (high-energy, motorcycle crash, vs. low-energy, a twisted
ankle). Clinicians are left to attempt to interpret physical exam findings and readings
from pressure monitors. Most importantly ACS is not an event, but a process that can
manifest at multiple points after injury. The most accurate and effective method for
diagnosing and appropriately treating ACS is serial examination over a course of hours to
days.

With this study, we hope to evaluate the NIRS device, which is non-invasive, as diagnostic
tool in the evaluation of acute compartment syndrome. We plan to evaluate all patients by
the gold standard in diagnosing acute compartment syndrome while simultaneously evaluating
the patient with the NIRS device. This will allow us to determine if the NIRS device can
accurately and reliably predict the development of acute compartment syndrome in a
non-invasive, longitudinal manner.

"Access to a precise, reliable, and noninvasive method for early diagnosis of ACS would be a
landmark achievement in orthopaedic and emergency medicine."

Inclusion Criteria:

- Patients will be included between the ages of thirteen and eighty-five who are
willing to participate and have unilateral lower leg injury with a fracture to the
tibia.

Exclusion Criteria:

- Patients will be excluded from enrollment if they have bilateral injuries to the
lower legs or have been previously diagnosed peripheral vascular disease. Patients
will also be excluded if they are not willing to participate.
We found this trial at
1
site
201 Dowman Dr
Atlanta, Georgia 30308
404.727.6123
Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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